Your Cells. Their Research. Your Permission?

JEFFREY GRAY, a professor at Des Moines University, recently instructed a room full of medical students to take out their phones. Unlock them, he said. Now pass them to the person behind you. They looked at him like, Are you nuts? They wanted to know, Why? What will they look at? How will they use that information?

“In other words, they wanted to be informed, and they wanted to give consent,” Dr. Gray said later. Now imagine those phones are cells in your body containing all the genetic information that makes you you, he told the students. Do you want scientists to pass them around and use them in research without your consent? Because right now, they can.

This often surprises people: Tissues from millions of Americans are used in research without their knowledge. These “clinical biospecimens” are leftovers from blood tests, biopsies and surgeries. If your identity is removed, scientists don’t have to ask your permission to use them. How people feel about this varies depending on everything from their relationship to their DNA to how they define life and death. Many bioethicists aren’t bothered by the research being done with those samples — without it we wouldn’t have some of our most important medical advances. What concerns them is that people don’t know they’re participating, or have a choice. This may be about to change.

The United States government recently proposed sweeping revisions to the Federal Policy for Protection of Human Subjects, or the Common Rule, which governs research on humans, tissues and genetic material. These changes will determine the content of consent forms for clinical trials, if and how your medical and genetic information can be used, how your privacy will be protected, and more. The most controversial change would require scientists to get consent for research on all biospecimens, even anonymous ones.

What’s riding on this? Maybe the future of human health. We’re in the era of precision medicine, which relies on genetic and other personal information to develop individualized treatments. Those advances depend on scientists working with vast amounts of human tissue and DNA. Dr. Francis S. Collins, director of the National Institutes of Health, believes involving donors in this process gives scientists more useful information, and can be life-changing for donors. In announcing plans for the $215 million Precision Medicine Initiative, which he sees as a model for other future research, Dr. Collins said, “Participants will be partners in research, not subjects.” But people can be partners only if they know they’re participating.

The original Common Rule was written decades before anyone imagined what we can now learn from biospecimens. Case in point: The Common Rule doesn’t require consent for “non-identifiable” samples, but scientists have proven it’s possible to “re-identify” anonymous samples using DNA and publicly available information. Nothing prohibits this. There is widespread agreement that current regulations are outdated, but little consensus on a fix. Much debate centers on what the public may or may not want done with their tissues, and whether that should even be a factor in policy making. What’s missing is the actual public.

The proposed changes are open for public comment on a government website through Jan. 6, but so far most comments are coming from scientists, research institutions, bioethicists and industry groups who strongly oppose the new consent requirements. Many favor the status quo; others want changes, but disagree with the ones proposed. Some question whether people even care what happens to a vial of blood or bits of a tumor after they leave the doctor. But trust me, they care.

People have told me by the thousands, and numerous public opinion studies find the same: They want to know if their biospecimens are used in research, and they want to be asked first. Most will probably say yes, because they understand it’s important. They just don’t want to find out later. That damages their trust in science and doctors. It makes them wonder, what else are you hiding from me?

People tell me this because I wrote a book about Henrietta Lacks, a black tobacco farmer whose cancer cells, taken without her knowledge in 1951, are still alive in laboratories worldwide. Those cells, code-named HeLa, were the first such cells grown and one of the most important advances in medicine. But they came with troubling consequences: Her children were later used in research, their medical information was published, and the HeLa genome — including personal information about Mrs. Lacks and potentially her descendants — was sequenced and posted online. All without the family’s knowledge.

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Mrs. Lacks’s story is unusual because she lost her anonymity. But I’ve talked to other still-anonymous donors with strikingly similar experiences. Like the Lacks family, they’re proud they helped science. They believe tissue research is important, but they wish they’d been asked permission from the start, to avoid difficulties that followed: the shock of learning they were part of research, debates over who controlled samples, questions over profits. I’ve also heard from scientists and medical professionals who believe this transparency is overdue. And patients who want to control their tissues to, say, ensure their samples are used to study only their specific rare disease.

So far, few of these people are part of the discussion. The Common Rule changes, like most such proposals, haven’t been widely publicized, and they’re laid out in a thick document even experts find confusing. But the Department of Health and Human Services has posted a brief summary and several explanatory videos. With few exceptions — like a public health emergency — the revised rule would require informed consent for research on all biospecimens, but not all genetic information inside them. How detailed that consent will be is up to researchers, but it can’t be less than “broad consent.” In a widely criticized move, the consent form template that would generally be required for “broad consent” hasn’t been released yet. Much of the debate has focused on what that form might look like, whether it can qualify as informed consent, and how much of a burden it might be.

According to sources involved in the rule-making process, “broad consent” would look like this: When you show up to the doctor, you’d get a form saying, essentially, We want to store your tissues for future biomedical research; we can’t tell you exactly what that research might involve, and you can’t specify how your tissues are used.We may share your identity with other researchers, with privacy protections in place. And we may contact you for future research. Is that O.K.?

That form would disclose any potential for commercial profit and whether donors would be compensated. Once you gave consent, those samples could be used in research indefinitely, and new samples could be collected for 10 years. Research on your stored samples generally would not require further consent or ethical review, unless a scientist wanted to share results with you from research done on your samples (a setup some critics see as a decrease in protection, and a disincentive to sharing information with donors). These requirements would apply only to future samples, not the millions already stored. And this could all change depending in part on public input.

Many commenters so far argue that these changes will lead to what they call “administrative burden” and decreased tissue access that will bring science to “a halt.” Some propose an opt-out system, making participation the default. Much concern centers on time, funding and how to track samples and consent. But some stems from misunderstanding. For example: Numerous comments from scientists say things like, “I CANNOT imagine needing to do this every time I request a sample from the blood bank.” But nothing would change for that scientist — existing anonymous samples wouldn’t require consent, and new ones would have been banked with consent. Many biobanks already use similar systems voluntarily. The only universal agreement seems to be on the need to educate the public about tissue research.

Here’s some of what the people revising the Common Rule would like to hear from the public: Should scientists have to ask permission to use all leftover clinical samples? Would you say yes? Is broad general consent enough, or do you want options for more control? Why? Should this apply to both tissues and genetic information, anonymous or not? And what if this slowed scientific progress?

People’s answers depend on many personal factors. Some believe their souls live on in the disembodied cells. Others feel anonymous biospecimens are of no consequence to the person they came from, so it’s unethical not to use them to advance science, especially since everyone hopes to benefit from such research when they’re sick. Some worry that genetic information will be linked to them, their families or their cultural group in harmful or discriminatory ways — particularly minorities.

I know many out there feel strongly about all of this. They have until Jan. 6 to tell the people making the rules.